# K152194: transGlide Expandable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Transaortic Medical, Inc.
- Decided: Apr 7, 2016 after 246 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K092014 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100819: The Solopath Balloon Expandable Transfemoral Introducer, Onset Medical Corporation (2010) Summary page 5.

## Most influential descendants
- K181817: transGlideXT Expandable Introducer (2019), 0 descendants of its own

## Indications for use
The transGlide Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

Source page: https://510kreport.com/device/K152194
Methodology: https://510kreport.com/methodology